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129Xe MRI in Pediatric Population With BPD

NCT04035629 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2026-02-05

No results posted yet for this study

Summary

Hyperpolarized (HP) gas magnetic resonance imaging (MRI) of the lungs offers additional information that cannot be obtained with CT scan, the current gold standard for imaging this disorder. As a nonionizing technique, MRI is an ideal modality for pulmonary imaging; in particular in the infant and pediatric population. Nevertheless, due to the low proton density of the lung parenchyma (only \~20% that of solid tissues), numerous air-tissue interfaces that lead to rapid signal decay, and cardiac and respiratory sources of motion that further degrade image quality , MRI has played a limited role in the evaluation of lung pathologies. In this setting, HP gas (using 129Xe) MRI may play a role in helping determine the regional distribution of alveolar sizes, partial pressure of oxygen, alveolar wall thickness, and gas transport efficiency of the microvasculature within the lungs of infants with a diagnosis of bronchopulmonary dysplasia (BPD).

Conditions

  • Bronchopulmonary Dysplasia

Interventions

COMBINATION_PRODUCT

MagniXene, hyperpolarized 129Xe MRI

All subjects will undergo hyperpolarized 129-Xenon MR imaging (HP MRI) and conventional proton MR imaging of lung. Hyperpolarized 129Xe gas is prepared in a process termed spin-exchange optical pumping. Xenon is highly lipophilic and therefore soluble in blood and tissue, making it an excellent tool for imaging the gas in both the air spaces (gas-phase imaging) and dissolved in the lung parenchyma (dissolved-phase imaging). This solubility in combination with xenon's chemical shift properties, results in the possibility of quantifying pulmonary gas exchange and gas transport within the parenchyma. Additionally, previous images and lung function tests will be reviewed to compare findings and evaluate if there is a correlation between the obtained results.

Sponsors & Collaborators

Principal Investigators

  • David M Biko, MD · Children's Hospital of Philadelphia

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2031-07-31
Completion
2031-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04035629 on ClinicalTrials.gov